510(k) Report

Devices descending from K014035

668 later devices reach Cooltouch and Cooltouch-II ND:Yag Laser Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172413MT ONEM&T S.R.L.20175—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K161669Waterlase ExpressBiolase, Inc.201621—
+5K152737Lite TouchFocus Medical, LLC20160—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152012EVO platformQuanta System Spa201537—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K142093V20 SystemViora, Ltd.201432—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K133774AtovenBio-Med USA, Inc.20146—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+5K131758Surgen UPollogen, Ltd.20135—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K103455Spectra Laser SystemLutronic Corporation201192—
+5K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K253765Vanish ProDdc Technologies, Inc.20260—
+6K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K260632Laser Thermal Therapy KitElesta S.P.A20260—
+6K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K252877SANDRO DualWontech Co., Ltd.20250—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K250165PastelleWontech Co., Ltd.20250—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K241527Pastelle ProWontech Co., Ltd.20253—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K240752Deka ToroEl.En S.P.A.20240—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K221761SoleaConvergent Dental, Inc.202201
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K221427V-LaserWontech Co., Ltd.20222—